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    Summary
    EudraCT Number:2006-006228-21
    Sponsor's Protocol Code Number:GPI-06-0002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-12
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2006-006228-21
    A.3Full title of the trial
    A PHASE II, MULTICENTER, OPEN-LABEL TRIAL EVALUATING THE
    ACTIVITY AND TOLERABILITY OF ROMIDEPSIN (DEPSIPEPTIDE, FK228)
    IN PROGRESSIVE OR RELAPSED PERIPHERAL T-CELL LYMPHOMA FOLLOWING PRIOR SYSTEMIC THERAPY
    A.3.2Name or abbreviated title of the trial where available
    Depsipeptide in PTCL
    A.4.1Sponsor's protocol code numberGPI-06-0002
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGloucester Pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/328
    D.3 Description of the IMP
    D.3.1Product nameRomidepsin
    D.3.2Product code FK228
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRomidepsin
    D.3.9.1CAS number 128517-07-7
    D.3.9.2Current sponsor codeFK228 / FR901228 / NSC630176
    D.3.9.3Other descriptive nameDepsipeptide
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.02 to 0.10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Progressive or relapsed Peripheral T-Cell Lymphoma (PTCL)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10034624
    E.1.2Term Peripheral T-cell lymphoma unspecified NOS
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to evaluate the activity of romidepsin in patients with progressive or relapsed PTCL following prior systemic therapy. The primary efficacy parameter is the rate of complete response, defined as the proportion of patients with complete response (CR) and unconfirmed complete response [CR(u)] according to the IWC for responses assessment for non-Hodgkin’s lymphomas (NHL).
    E.2.2Secondary objectives of the trial
    • To estimate the rate of objective disease response (ORR), defined as the proportion of patients with CR, CR(u), and partial response (PR);
    • To estimate the duration of response, defined as the time from the first date of a disease response to the date of diagnosis of progressive disease (PD) or date of last study assessment if there is no disease progression;
    • To estimate the time to objective disease progression;
    • To assess tolerability and safety of romidepsin; and
    • To estimate the change in Eastern Cooperative Oncology Group (ECOG) performance status.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically confirmed PTCL NOS, angioimmunoblastic T-cell lymphoma, extranodal NK/T-cell lymphoma nasal type, enteropathy- type T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cutaneous  T-cell lymphoma (excludes mycosis fungoides or Sézary syndrome), transformed mycosis fungoides, hepatosplenic T-cell lymphoma, ALCL (ALK-1 negative), or patients with ALK 1 expressing ALCL (ALK-1 positive) who have relapsed disease after ASCT;
    • Age ≥18 years;
    • Written informed consent (see Appendix A);
    • PD following at least one systemic therapy or refractory to at least one prior systemic therapy;
    • Measurable disease according to the IWC criteria (see Appendix B) and/or measurable cutaneous disease;
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix C);
    • Serum potassium ≥3.8 mmol/L and magnesium ≥0.85 mmol/L (magnesium converts to 2.0 mg/dl or 1.7 mEq/L) (electrolyte abnormalities can be corrected with supplementation to meet inclusion criteria);
    • Negative urine or serum pregnancy test on females of childbearing potential; and
    • All women of childbearing potential must use an effective barrier method of contraception (either an intrauterine contraceptive device [IUCD] or double barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter. Male patients should use a barrier method of contraception during the treatment period and for at least 3 months thereafter. Hormonal methods of contraception such as the contraceptive pill or patch (particularly those containing ethinyl-estradiol) should be avoided due to a potential drug interaction
    E.4Principal exclusion criteria
    • • Known central nervous system (CNS) lymphoma [computed tomography (CT) or magnetic resonance imaging (MRI) scans are required only if brain metastasis is suspected clinically];
    • Chemotherapy or immunotherapy within 4 weeks of study entry (6 weeks if nitrosoureas given);
    • Initiation of corticosteroids during study (defined as 7 days prior to C1D1 until study drug discontinuation)
    o Patients treated with a pulse of steroids must discontinue steroid use 7 days prior to C1D1 and have a repeat CT scan and disease assessment after discontinuation of corticosteroids and before starting romidepsin;
    • Any known cardiac abnormalities such as:
    o Congenital long QT syndrome;
    o QTc interval >480 milliseconds (msec);
    o Myocardial infarction within 6 months of C1D1. Subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate;
    o Other significant ECG abnormalities including 2nd° atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min).
    o Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV In any patient in whom there is doubt, the patient should be referred to a cardiologist for evaluation;
    o An ECG recorded at screening showing significant ST depression (ST depression of ≥2 mm, measured from isoelectric line to the ST segment at a point 60 msec at the end of the QRS complex). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;
    o Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions (see Appendix F) and/or ejection fraction <40% by MUGA scan or <50% by echocardiogram and/or MRI;
    o A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD);
    o Hypertrophic cardiomyopathy or restrictive cardiomyopathy from prior treatment or other causes (if in doubt, see ejection fraction criteria above);
    o Uncontrolled hypertension, i.e., blood pressure (BP) of ≥160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria.
    o Any cardiac arrhythmia requiring anti-arrhythmic medication;
    • Serum potassium <3.8 mmol/L or serum magnesium <0.85 mmol/L (magnesium converts to 2.0 mg/dl or 1.7 mEq/L) (electrolyte abnormalities can be corrected with supplementation to meet inclusion criteria);
    • Concomitant use of drugs that may cause a significant prolongation of the QTc
    • Concomitant use of CYP3A4 significant or moderate inhibitors (
    • Concomitant use of therapeutic warfarin or another anticoagulant due to a potential drug interaction. Use of a small dose of anticoagulant to maintain patency of venous access port and cannulas is permitted.
    • Clinically significant active infection;
    • Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;
    • Previous extensive radiotherapy involving ≥30% of bone marrow (e.g., whole pelvis, half spine), excluding patients who have had total body irradiation as part of a conditioning regimen for ASCT;
    • Major surgery within 2 weeks of study entry (C1D1);
    • Previous allogeneic stem cell transplant;
    • Inadequate bone marrow or other organ function as evidenced by:
    o Hemoglobin <9 g/dL (transfusions and/or erythropoietin are permitted);
    o Absolute neutrophil count (ANC) ≤1.0 × 109 cells/L [patients with neutropenia (ANC 1–1.5) as a function of their disease may be supported with granulocyte-colony stimulating factor (G-CSF)];
    o Platelet count <100 × 109 cells/L or platelet count <75 × 109 cells/L if bone marrow disease involvement is documented;
    o Total bilirubin >2.0 × upper limit of normal (ULN) or >3.0 × ULN in the presence of demonstrable liver metastases;
    o Aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >2.0 × ULN or >3.0 × ULN in the presence of demonstrable liver metastases; or
    o Serum creatinine >2.0 × ULN;
    • Patients who are pregnant or breast-feeding;
    • Coexistent second malignancy or history of prior solid organ malignancy within previous 3 years (excluding basal or squamous cell carcinoma of the skin, and in situ carcinoma of the cervix (CIN 3) that has been treated curatively);
    E.5 End points
    E.5.1Primary end point(s)
    • CR (Complete Response) : For the purposes of reviewing radiology, CR is defined as the complete disappearance of all radiographic evidence of disease. All large Nodal Index lesions (identified as abnormal lymph nodes or nodal masses > 15mm at baseline) must have decreased to ≤15 mm in their greatest diameter. All small Nodal Index lesions (identified as abnormal lymph nodes or nodal masses between 11mm and 15mm at baseline) must have decreased to ≤10 mm in their greatest diameter or,in aggregate, those lesions must have regressed >75% in their SPD compared to baseline. If the spleen or liver is considered to have been enlarged before therapy due to involvement by lymphoma, it must have regressed in size. Any macroscopic nodules detectable in any organs should no longer be present.
    • CR(u) (Complete Response unconfirmed): Includes all the criteria for CR listed above except that all Nodal Index lesions (large or small) must have regressed > than 75% in the SPD from baseline. Individual nodes that were previously confluent must have regressed by > 75% in their SPD compared to the SPD of the original mass.
    • PR (Partial Response): Requires all of the following: 1) ≥50% decrease in SPD of the six largest dominant nodes or nodal massess; 2) Extranodal Index lesions must also decrease by ≥50% from baseline in their SPD (can include hepatic and splenic nodules); 3) no obvious increase in the size of Non-Index lesions, liver, or spleen; and 4) no new sites of disease (defined as no new node >10 mm in greatest diameter and no newly detectable lesions).
    • SD (Stable Disease): To be considered SD, lesions must not meet the criteria for PR listed above, and should not qualify for PD.
    • PD (Progressive Disease) : Requires either of the following: 1) Appearance of any new lesion defined as a new node >10 mm in greatest diameter or a newly detectable extranodal lesion;
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-01-12. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    If still responding after 6 cycles, may continue on FK228 until progression, unacceptable toxicity, or another withdrawal criterion is met. Otherwise, normal treatment at the Investigator’s discretion will continue.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-11-29
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